The undersigned organizations advocate on behalf of people with cancer,
their caregivers and not-for-profit organizations that fund cancer research.
For cancer patients, there is no more important provision in the Patients'
Bill of Rights than the requirement of coverage of routine patient care
costs for persons enrolled in cancer clinical trials. Only through support
of clinical researchincluding required payment for routine patient
care costswill patients have access to potentially life-extending
cutting-edge therapies, and society as a whole will make progress against
cancer, a major source of morbidity and mortality in this country.

Over the course of
the past few years, the Congress has made and thus far honored a commitment
to double the budget of the National Institutes of Health as a way to
take advantage of the many opportunities now presented by biomedical research
discoveries. This investment will be optimized only if the health care
system does its part so that research discoveries will be translated into
clinical applications that will reach patients. The responsibility of
health plans is to honor insurance contracts by covering routine patient
care costs. We emphasize that these costsincluding such matters
as the usual physician and hospital charges and routine diagnostic testsare
normally borne by third-party payers, and the fact that they are incurred
in the context of a clinical trial does not relieve payers of their obligation.
If the clinical trial is permitted to excuse payers from responsibility
for covering these routine costs, the payers will receive a great windfall
and patients will be deprived of the value of their insurance.

While we are very
supportive of cancer clinical trials coverage and appreciative of those
who have championed it, it is important to note that covering only government-sponsored trials, such as those emanating from NIH, will address only half the problem. It is estimated that trials sponsored by NIH and other government agencies include no more than about half of all new cancer therapies. The other
half are in trials sponsored by industry. Not infrequently, it is these
industry-sponsored trials that offer the new agents so desperately sought
by cancer patients. The review to which these industry-sponsored trials
are subjected by the Food and Drug Administration is at least as rigorous
medically, scientifically and ethically as those reviewed by NIH or other
funding agencies. Complete relief requires that coverage be extended to
industry- sponsored cancer clinical trials reviewed by FDA.

As you enter deliberations
over a final Patients' Bill of Rights, we speak for more than 8 million
cancer survivors in urging you to include a provision requiring coverage
of routine patient care costs for those enrolled in high-quality cancer
clinical trials, whether sponsored by government funding agencies or by
industry after review by FDA. In doing so, you will be enhancing the quality
of care for people with cancer while also ensuring that medical progress
against this terrible disease will continue.